Advanced Pharma Recalls Early Baby TPN Due to Latex Labeling
Advanced Pharma Inc. is recalling Early Baby TPN (Neonatal) because the product may contain synthetic or natural latex, which is not currently labeled.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to a labeling error regarding latex content, which fits the rubric for minor labeling errors or low-risk contamination without reported injuries.
Plain-English summary
Advanced Pharma Inc. is recalling Early Baby TPN (Neonatal) in all strengths, dosage forms, and packaging. The product is prescription-only and was distributed nationwide in the United States. The recall involves all lots of the product.
The recall was initiated due to a labeling issue. The product may contain synthetic latex and/or natural latex, but this information is not currently classified or labeled on the product. This is a Class II recall, indicating a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should discontinue use of the affected product. Consumers should contact their healthcare provider for guidance on alternative treatments or further instructions.
The recalled product
- Product
- Early Baby TPN (Neonatal) all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Parenteral Nutrition
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 60 recalled by Advanced Pharma Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 60 products in this recall →Related recalls
Same manufacturer · Advanced Pharma Inc.
See all →- HighAdvanced Pharma Recalls Sub-Potent Hydromorphone Injectable Solution
FDA (Drugs) · 2019-05-08
- SevereAdvanced Pharma Recalls Lidocaine Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-03-27
- HighAdvanced Pharma Recalls Glycopyrrolate Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-03-27
- SevereAdvanced Pharma Recalls Heparin Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-03-27
- SevereAdvanced Pharma Recalls Phenylephrine HCl Injectable Solution Due to Sterility Concerns
FDA (Drugs) · 2019-03-27
Same hazard · latex allergen
See all →- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateHalyard Total Joint Kits Recalled for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits Due to Latex Labeling Error
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOASIS MRI table pads recalled for missing latex allergen labeling
FDA (Devices) · 2021-09-01